Medicine
Fidaxomicin 200 mg tablet
Fidaxomicin 200 mg tablet is a generic prescription medicine for oral use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store fidaxomicin tablets at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Fidaxomicin
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 20 tablets, 1 bottle and 2 more
- Manufacturers
- Torrent PharmaceuticalsIndiaApotexHikma PharmaceuticalsSandozTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store fidaxomicin tablets at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original bottle.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07AA12 Fidaxomicin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 July 2025
- Identifiers
- RxCUI 1111106DailyMed set ID 6cc3e803-8935-f9b3-ab7f-fef8b1c02070, 8f68f0cb-9573-4d5a-8f31-a93dd2706691, d773c5ee-9361-49b0-871b-af34f3f936be +2NDC 60505-4833, 13668-745, 0054-0795 +2Application ANDA219559, ANDA220374, ANDA219737 +2
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 20 tablet, film coated in 1 bottle | 13668-745-21 | Torrent PharmaceuticalsIndia | 27 January 2026 |
| 1 bottle in 1 carton / 20 tablet, film coated in 1 bottle | 60505-4833-2 | Apotex | 3 February 2026 |
| 20 tablet, coated in 1 bottle | 0054-0795-07 | Hikma Pharmceuticals | 7 October 2026 |
| 20 tablet, film coated in 1 bottle | 0781-5194-20 | Sandoz | 27 August 2026 |
| 20 tablet, film coated in 1 bottle | 0480-2596-34 | Teva Pharmaceuticals | 15 July 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fidaxomicin 200 mg tablet.
Other strengths and forms of Fidaxomicin
Clinical summary
Fidaxomicin is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea, among other approved uses. It is available as tablets and oral suspension. MedsAcross supplies Fidaxomicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FidaxomicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dificid prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Dificlir: European public assessment report (EPAR) · European Medicines Agency
Need Fidaxomicin 200 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.